Status:
COMPLETED
Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker
Lead Sponsor:
Otsuka Beijing Research Institute
Conditions:
Type 2 Diabetes Mellitus
Arteriosclerosis Obliterans
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker 2. To evaluate the safety of Cilostazol and Probucol alone and in combination on at...
Detailed Description
Efficacy evaluation: Primary efficacy index: After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information Secondary e...
Eligibility Criteria
Inclusion
- 40\~75-year-old male or female
- Clarified diagnosis of type 2 diabetes mellitus
- Arteriosclerosis obliterans (ASO) is diagnosed (ASO diagnoses should meet at least one of the conditions as below:
- ABI\<1.0;
- The pulse of popliteal artery or dorsalis pedis artery is weeken significantly or is different between left and right sides
- Intermittent claudication, diagnosed as ASO by doctor
- Ultrasonogram showed that there was atherosclerotic plaque in lower limb within 1 year
- Informed Consent Form Signature
Exclusion
- Has an allergic history to study drugs
- Use one of the following drugs: other antiplatelet or anticoagulation agents except Aspirin, other hypolipidemic agents except Statins
- Type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetes mellitus
- Has severe ASO above Fontaine IIb,
- Hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tract hemorrhage, etc.)
- Had a myocardial infarction, angina pectoris, or cerebral infarction within the last 3 months
- Congestive heart failure
- Is pregnant, or potentially pregnant, or breastfeeding
- Severe hepatic insufficient or severe renal insufficiency (AST or ALT is 2.5 times higher than the upper limit of the normal value range, or serum creatinine is 1.2 times higher than the upper limit of the normal value range)
- Persistent or hardly controlled hypertension (such as malignant hypertension, BP\> 160/100 mmHg)
- Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
- Has a medical history that includes a cardiac syncope or a primary syncope
- Has conditions that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
- Has severe complications (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)
- Other conditions that would exclude the subject from this study by doctor's judgement
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00823849
Start Date
October 1 2008
End Date
March 1 2010
Last Update
March 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University First Hospital
Beijing, China